Z-0847-2014Class II

Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class...

Name: Z-0847-2014 Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class...
Creator: Zimmer Dental Inc
Published: 2014-01-06
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2014-01-06 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Dental Inc began a recall of Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227 on 2014-01-06. FDA classified it as Class II and gives the reason as "Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0847-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Posted: 2014-01-28
Terminated: 2014-07-07
Recalling firm: ZimVie US Corp LLC
Product: Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.
Quantity in commerce: 307
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
Product codes and lots: Catalog Number TSVWB11, Lot 62470008.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0847-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0847-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code DZE

K072589Class IITapered Screw-Vent Implant, 4.1Mm, Models: Tsv4b8, B10, B11, B13 and B16, Tsv4h8, H11, H13 and H16Zimmer Dental, Inc. / cleared 2007-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)